Merck Presents Early-Stage Interim Data for MK-3475, an Investigational Therapy for the Treatment of Advanced Melanoma

  Merck Presents Early-Stage Interim Data for MK-3475, an Investigational
  Therapy for the Treatment of Advanced Melanoma

                        Phase II Study Being Initiated

Business Wire

WHITEHOUSE STATION, N.J. -- November 11, 2012

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced the presentation of early interim results from a single-arm,
open-label Phase IB study that has so far enrolled 132 patients with advanced
(inoperable and metastatic) melanoma who have received MK-3475, Merck’s
investigational immune-modulating therapy.Omid Hamid, M.D., Director of the
Melanoma Center at the Angeles Clinic and Research Institute, Los Angeles,
presented the data during a late-breaking clinical trials session at the
Society for Melanoma Research of the 9th International Congress of the Society
for Melanoma Research (SMR) in Hollywood, Calif.

"A key element of Merck’s oncology strategy is to identify therapeutic
candidates with the potential to make a meaningful difference for patients
with difficult-to-treat cancers," said Gary Gilliland M.D., Ph.D., senior vice
president and oncology franchise head, Merck Research Laboratories. "Based
upon the severe unmet medical need in advanced melanoma and the early interim
results from this clinical trial, Merck is moving ahead with a clinical
development program designed to analyze MK-3475 in a larger advanced melanoma
population."

Patients were administered MK-3475 in one of three regimens: low dose every 3
weeks, high dose every 3 weeks and high dose every 2 weeks. Following an
initial disease evaluation, patients received one of the three regimens of
MK-3475. After 12 weeks, disease status was evaluated by the investigator and
compared to baseline using immune-related response criteria (irRC). Those
patients demonstrating stable disease or response at the 12-week evaluation
time point continued to receive MK-3475 and follow-up monitoring.

Data has so far been obtained for 85 of the 132 patients enrolled in the
study. Of those patients, a total of 43 patients (51 percent) showed an
objective anti-tumor response, and of those, 8 patients (9 percent) showed a
complete response at or after the 12-week assessment. Notably, of the 27
patients who had previously been treated with ipilimumab monotherapy, the
current standard of care for late-stage melanoma, 11 patients (41 percent)
showed an objective anti-tumor response to MK-3475 monotherapy; none of those
patients showed a complete response.

The most common adverse events experienced by patients who received MK-3475
included fatigue, rash, diarrhea, nausea, cough, joint pain, fever and
itching. Seven MK-3475 related Grade 3/4 adverse events were reported as
potentially “immune related.”

Merck recently initiated a global, randomized, Phase II clinical trial to
evaluate MK-3475 versus standard chemotherapy for participants with advanced
melanoma whose disease has progressed after prior therapy (reference:
NCT01704287). Participants will be randomized to receive one of two doses of
MK-3475 or investigator-choice chemotherapy. For further information, please
visit http://www.clinicaltrials.gov.

About PD-1 and MK-3475

Research has shown that PD-1, an immune checkpoint receptor, helps to confer
immune resistance for some cancers allowing tumor cells to grow and
proliferate unchecked.MK-3475 is a monoclonal antibody designed to target
PD-1 to disrupt the role PD-1 plays in resisting the immune system.

About Merck

Today's Merck is a global healthcare leader working to help the world be well.
Merck is known as MSD outside the United States and Canada. Through our
prescription medicines, vaccines, biologic therapies, and consumer care and
animal health products, we work with customers and operate in more than 140
countries to deliver innovative health solutions. We also demonstrate our
commitment to increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit www.merck.com and
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and Exchange Commission (SEC) available at the SEC's Internet site
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